BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSITE X  EP SYSTEM AMPLIFIER

    MDR report key: 14620585 · Received June 7, 2022

    Report

    Report Number
    2184149-2022-00142
    Event Type
    Malfunction
    Date Received
    June 7, 2022
    Date of Event
    May 17, 2022
    Report Date
    June 7, 2022
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    DQK
    UDI-DI
    05415067034755
    PMA / PMN Number
    K202066
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE ENSITE X AMPLIFIER WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED THE FRONT PORTS, AND CHASSIS WERE FREE OF PHYSICAL DAMAGE. THE CAT5E SMALL FORM-FACTOR PLUGGABLE (SFP) WAS BENT FROM AN UNDETERMINED EVENT. THE REAR DC POWER COUPLER HAS SOME PHYSICAL DAMAGE FROM AN UNDETERMINED EVENT. FOR EVALUATION PURPOSES THE PORT 3 AND PORT 4 SFP WERE EXCHANGED. THE AMPLIFIER WAS POWERED ON AND THEN THE AMPLIFIER BOOTED TO A FLASHING ORANGE ¿NOT-READY¿ LED STATUS. THIS INDICATED THE AMPLIFIER DID NOT PASS THE POWER-ON-SELF-TEST (POST) ALTHOUGH THE TEST STATION AND TRACKER COMMUNICATED SUCCESSFULLY, HOWEVER THERE WAS MULTIPLE MESSAGES THAT SAID ¿ERROR15¿. THE SERVICE TOOL WAS THEN CONNECTED WITH USE OF PUTTY SOFTWARE TO OBSERVE THE POST SEQUENCING. IT WAS THEN OBSERVED THAT THE POST HAD NIOS SYMPTOMS ATTRIBUTED TO SLOT WHICH CAUSED THE POST CONDITION. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. THE REVIEW DETERMINED THAT NO NON-CONFORMANCES ASSOCIATED WITH THE REPORTED EVENT WERE IDENTIFIED. BASED ON THE INFORMATION PROVIDED TO ABBOTT AND THE INVESTIGATION PERFORMED, THE REPORTED EVENT WAS DUE TO THE SLOT 0 CARDIAMP BOARD.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: E1.

    Description of Event or Problem · 0

    DURING THE PROCEDURE, THE AMPLIFIER WAS FLASHING ORANGE WHICH CAUSED A DELAY. THE AMPLIFIER WAS REBOOTED WITH NO RESOLUTION AND AN AMPLIFIER FROM A DIFFERENT HOSPITAL HAD TO BE OBTAINED TO COMPLETE THE CASE WITH NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1141240 ENSITE X  EP SYSTEM AMPLIFIER COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK ST. JUDE MEDICAL, INC. ENSITE-AMP-02 8164124 05415067034755

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown